Consumer Information for: APO-LABETALOL

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

APO-LABETALOL is used to treat high blood pressure (also known as hypertension) in adults. APOLABETALOL can be used alone or with other medicines to treat this condition.

What it does

APO-LABETALOL belongs to a group of drugs called “beta-blockers”.

  • It makes your heart beat more slowly and less forcefully.
  • It lowers your blood pressure by relaxing your blood vessels so that your blood flows more easily.

This medicine does not cure your disease but helps to control it. Therefore it is important to continue taking APO-LABETALOL regularly even if you feel fine.

When it should not be used

  • Are allergic or hypersensitive to labetalol hydrochloride or to any of the other ingredients in APOLABETALOL.
  • Have heart failure and you notice that your symptoms are getting worse. For example, you feel more tired, are out of breath more often, or have swelling of the ankles.
  • Have severe heart damage and your heart is not able to pump enough blood to meet your body’s needs.
  • Have a slow or irregular heartbeat.
  • Have a problem with your heart’s electrical conduction (that causes you to have chest pain, difficulty breathing, nausea, fatigue and fainting).
  • Have asthma or other lung problems (like bronchitis or emphysema).
  • Have serious problems with blood flow in your feet and legs (severe peripheral artery disease).
  • Are less than 18 years old.
What the medicinal ingredient is

labetalol hydrochloride

What the non-medicinal ingredients are

colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, methylcellulose, polyethylene glycol, purified water, titanium dioxide. APO-LABETALOL 100 mg Tablets also contain the following colouring agents: D&C Yellow #10 Aluminum Lake 16%, FD&C Yellow #6 Aluminum Lake 40%.

What dosage form it comes in

Tablets: 100 mg and 200 mg

Warnings and precautions

  • Have a history of heart problems.
  • Have a history of fainting.
  • Have diabetes and take medicine to control your blood sugar or have low blood sugar (hypoglycemia).
  • Have a condition called pheochromocytoma (a tumour of the adrenal gland).
  • Have thyroid problems.
  • Have liver problems.
  • Have had allergic reactions or have allergies.
  • Are pregnant or trying to become pregnant. APO-LABETALOL is not usually recommended for use during pregnancy. Your doctor will consider the benefit to you versus the risk to your unborn baby.
  • Are breastfeeding. You should not breastfeed while using APO-LABETALOL.
  • Are scheduled for surgery and will be given an anesthetic.
  • Develop a skin rash while taking APO-LABETALOL.

Other warnings you should know about

Do not stop taking APO-LABETALOL suddenly. This could cause chest pain or a heart attack. If your doctor decides that you should stop taking APO-LABETALOL, your dose may be reduced so that you need to use less and less before you stop the medicine completely.

The results of urine tests may be affected by taking APO-LABETALOL. If you need to have a urine test, tell your doctor that you have been given APO-LABETALOL tablets.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Interactions with this medication
  • Drugs used to treat high blood pressure, such as:
    • Diuretics (“water pills”)
    • ACE inhibitors
    • Calcium channel blockers (e.g. diltiazem, verapamil)
  • Anesthetic drugs used during surgery (e.g. halothane)
  • Drugs used to prevent angina (e.g. nitroglycerin)
  • Drugs used to treat heartburn and stomach ulcers (e.g. cimetidine)
  • Drugs used to treat depression (e.g. tricyclic antidepressants)
  • Drugs used to treat multiple sclerosis (e.g. fingolimod)

Proper use of this medication

Your doctor will determine your dose based on your individual medical needs and will tell you when and how to take APO-LABETALOL. Take APO-LABETALOL exactly as prescribed. APO-LABETALOL should be taken preferably after food.

Usual adult dose

Starting daily dose: 100 mg twice a day
Daily maintenance dose: 200 to 400 mg twice a day
Maximum daily dose: 1200 mg per day (600 mg twice a day)

Your doctor may:

  • Start you on a different dose or change your dose over time depending on how APO-LABETALOL works for you.
  • Add another medicine like a diuretic (“water pill”) or an ACE inhibitor for you to take along with APOLABETALOL to treat your high blood pressure.

Do not stop taking APO-LABETALOL or change your dose without first consulting your doctor. This can be dangerous.

For elderly patients and patients with liver problems:

Smaller doses are generally used in older patients, and those with liver problems.

Overdose

If you think you have taken too much APO-LABETALOL, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Side effects and what to do about them

These are not all the possible side effects you may feel when taking APO-LABETALOL. If you experience any side effects not listed here, contact your healthcare professional. Please also see Warnings and Precautions.

Side effects may include:

  • Dizziness
  • Headache
  • Nausea/Vomiting
  • Tiredness
Serious side effects and what to do about them
Symptom / effect Talk to your healthcare professional Only if severe Talk to your healthcare professional In all cases Stop taking drug and get immediate medical help
Common
Hypotension (low blood pressure): dizziness or lightheadedness leading to fainting can occur when changing positions, for example from lying down to standing up   ✔  
Chest pain     ✔
Uncommon
Bradycardia: decreased heart rate that causes you to be dizzy or faint   ✔  
Allergic reactions: rash, swelling of the lips, face or neck, difficulty breathing or speaking     ✔
Congestive heart failure: irregular heartbeat, low heart rate, or other changes in heart symptoms   ✔  
Narrowing of the airways (bronchospasm) or other lung effects   ✔  
Liver disorders: yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite     ✔
UNKNOWN FREQUENCY
Lupus-like syndrome: joint pain, muscle pain, chest pain when you cough or breath, breathing difficulties (shortness of breath or labored breathing)   ✔  

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

How to store

Store at room temperature 15°C to 30°C. Protect from light.

Keep out of reach and sight of children.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

More information

This leaflet was prepared by Apotex Inc. Toronto, Ontario, M9L 1T9.

Last revised: August 24, 2020

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